Antimicrobial &amp; antiviral composition

ABSTRACT

An antimicrobial and antiviral barrier composition for topical application to the proximal anterior nares includes an antiseptic solution in combination with cocos nucifera (coconut oil) and one or more citrus oils such as, for example, citrus sinensis (orange oil). Various embodiments may also include one or more of the following additional ingredients: lauric acid; d-limonene; soy oil; emu oil; grapefruit seed extract; glycine soja; simmondsia chimensis (Jojoba); aloe vera; and a preservative, such as sodium benzoate, BHT, benzalkonium chloride, vitamin E.

BACKGROUND OF THE INVENTION

This patent application is a divisional patent application of co-pendingpatent application Ser. No. 11/906,640 filed on Oct. 3, 2007 which is aContinuation-In-Part (CIP) patent application of patent application Ser.No. 11/189,242 filed on Jul. 26, 2005, now abandoned.

FIELD OF THE INVENTION

This invention relates to antiseptic compositions and, moreparticularly, to a nasal antiseptic barrier composition havingantimicrobial, antiviral, and antifungal properties.

DISCUSSION OF THE RELATED ART

In recent years, outbreaks of new and potentially deadly diseases suchas Severe Acute Respiratory Syndrome (SARS) and the Avian Influenza havecaptured worldwide attention and concern. New and unusual strains of theflu virus have also emerged in the last few years and have spreadthroughout the world population at epidemic levels. It is believed thatincreases in world population, rapid travel between distance regions andhigh concentration of individuals in confined areas where there is poorair filtration (e.g. aircraft, trains, buses and tourist sites) haveresulted in the increase in the number of, as well as mutation of,pathogenic organisms.

The onset of respiratory disease is primarily a result of inhalation ofairborne pathogens through the nose and mouth. However, the oral cavityis better equipped to kill airborne pathogens before they can enter andinfect the body. Specifically, saliva in the mouth captures manyairborne pathogens before they are inhaled into the lungs. Once thesaliva containing the pathogens is swallowed, stomach acids are highlyeffective in killing these pathogens before they can infect the body.The nasal passages, on the other hand, are less effective in trappingand killing microorganisms. Airborne pathogens inhaled through the noseusually enter the lungs where there can cause respiratory infection orother types of infection once these pathogens enter the blood stream.

World wide concern of epidemic outbreaks has lead to more drasticpreventative measures including emergency mass production of newvaccines. Individuals have adopted preventive practices such as frequenthand washing and use of antiseptic hand lotions and wipes. While theseare good practices to help reduce the possibility of infection, they arenot long lasting and are usually only effective to kill germs that wereon the hands or other areas of the body prior to cleansing. With littleto no residual effect, the hands can become contaminated with pathogensshortly after washing.

Some societies have begun to use face masks as a means of protectionagainst respiratory infections. Face masks are effective to prevententry of pathogens into the respiratory system. However, the use of facemasks is generally impractical, inefficient and socially unappealing.

Besides the concern for the health and well beings of individuals thereare economic interests in preventing the spread on communicablediseases. For instance, over the course of just one year Americanssuffer approximately 1 billion colds. The economic impact of the commoncold is enormous. The National Center for Health Statistics (NCHS)estimates that over 70 million cases of the common cold in the UnitedStates required medical attention or resulted in restricted activities.Colds cause more than 50 million days of restricted activity and 25million days lost from school and the work place. Overall, the estimatedcost to the U.S. economy of the common cold and other related illnessesis approximately $150 billion per year.

Accordingly, there is an immediate need for more effective protectionmeasures to decrease the spread of disease, and particularly respiratoryinfections that result from exposure to airborne pathogens.

SUMMARY OF THE INVENTION

The present invention is directed to an antimicrobial and antifungalbarrier composition for topical application to the proximal anteriornares (rim surrounding the nostrils). The composition includes anantiseptic solution in combination with cocos nucifera (coconut oil) andone or more citrus oils such as, for example, citrus sinensis (orangeoil). Examples of an antiseptic solution include one or more alcohols,such as ethyl alcohol, or hydrogen peroxide. The composition may includeone or more additional ingredients, including: lauric acid; simmondsiachinensis (Jojoba); d-limonene; soy oil; emu oil; grapefruit seedextract; glycine soja; aloe vera and a preservative, such as sodiumbenzoate, benzalkonium chloride, BHT and vitamin E.

When properly applied to the skin surrounding the nostril openings, thecomposition has been proven effective in killing 99.99999% (7 log) orgreater germs. This extremely efficient antimicrobial efficiencypersists for at least 8 hours. Results from laboratory studies haveshown efficacy in killing streptococcus (pneumoniae and pyogenes),staphylococcus aureus, mycobacterium smegmatis, and haemophilusinfluenza bacterias. The antimicrobial and antiviral composition of thepresent invention was further shown to be effective in eradicating therhinovirus and influenza A virus (avian flu), as well as the coronavirus. The corona virus is known to be the cause of SARS.

In addition to the anti-pathogen properties, the composition of thepresent invention has also been proven to help alleviate the body'simmuno-response to many allergens including, but not limited to, dustmites, pollen, hay fever, animal dander, dust, particulate pollution,ozone, sulfur dioxide, and nitrogen oxide. The composition is effectivein trapping these allergens and alleviating the body's response to theirpresence. In the case of ozone, SO2 and NO, the composition acts as abarrier in the nose and lessens the IGA response in the body. It is alsobelieved that the composition works to lessen the Interleukin expressionin the nose, especially ILB, commonly perspective for the inflammationresponse in the nasal cavity. A particularly effective formulationincludes one or more of the following ingredients in combination withcitrus oils, cocos nucifera and glycine soja: beeswax; bees milk; andfruit wax.

Objects and Advantages of the Invention

Considering the forgoing, it is a primary object of the presentinvention to provide an antimicrobial and antiviral composition fortopical application to the anterior nostril openings for protectingagainst harmful exposure to airborne pathogens.

It is a further object of the present invention to provide a safe andhighly effective antimicrobial and antiviral composition for topicalapplication to the rim of each nostril to provide protection against abroad spectrum of harmful pathogens for at least 8 hours.

It is still a further object of the present invention to provide anantimicrobial and antiviral composition for topical application to therim of each nostril to enhance the natural filtration properties of thenose.

It is yet a further object of the present invention to provide anantimicrobial and antiviral composition for topical application to therim of the nostrils for trapping and killing airborne pathogens beforethese pathogens can replicate within the nasal cavity.

It is still a further object of the present invention to provide anantimicrobial and antiviral composition that significantly reduces thenumber of harmful pathogens that proliferate freely within the nasalcavity, thereby minimizing the degree and severity of potentialrespiratory infection.

It is still a further object of the present invention to provide anantimicrobial and antiviral composition of topical application to therim of the nostrils, and wherein the composition has a pleasant scentand contributes to the lubrication and filtration of the nasal passages.

It is yet a further object of the present invention to provide anantimicrobial and antiviral composition for topical application to therim of the nostrils, wherein the composition is effective in trappingallergens and alleviating the body's response to their presence.

These and other objects of the present invention are more readilyapparent with reference to the detailed description which follows.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is directed to a long lasting antimicrobial andantiviral barrier composition for topical application to the proximalanterior nares (skin surface surrounding the opening of the nostrils).The antimicrobial and antiviral composition of the present inventionincorporates the use of one or more antiseptic solutions in combinationwith cocos nucifera (coconut oil), citrus sinensis (orange oil), andsimmondsia chinensis (Jojoba). In one preferred embodiment, theantiseptic solution is USP ethyl alcohol. In another preferredembodiment, the antiseptic solution is hydrogen peroxide. Other alcoholsand antiseptic agents are contemplated for use in the composition as theantiseptic solution, either alone or as a combination.

The essential ingredients of the composition are present according tothe following percentages by weight of the composition:

Amount Additional Ingredients (% by Weight of the Composition)Antiseptic solution between 5% and 75% Citrus Sinensis between 0.05% and60% Cocos Nucifera between 0.025% and 70%

The antimicrobial and antiviral composition of the present invention mayfurther include the following additional ingredients, alone or incombination: lauric acid; simmondsia chinensis; d-limonene; soy oil; emuoil; grapefruit seed extract; glycine soja; and a preservative such assodium benzoate, benzalkonium chloride, BHT, vitamin E. These additionalingredients of the composition are present according to the followingpercentages by weight of the composition:

Amount Additional Ingredients (% by Weight of the Composition) Lauricacid between 0.01% and 5% Simmondsia Chinensis between 0.1% and 75%D-limonene between 0.01% and 5% Glycine Soja (soy oil) between 0.1% and80% Emu oil between 0.1% and 10% Grapefruit Seed extract between 0.1%and 8% Aloe Vera between 0.1% and 30% Benzalkonium Chloride between 0.1%and 5% BHT between 0.05% and 2% Vitamin E between 0.1% and 4%

A further embodiment of the composition has been proven to helpalleviate the body's immune-response to many allergens and pollutants.The following ingredients have been found to be effective in thecomposition when present according to the following percentages byweight of the composition:

Amount Ingredients (% by Weight of the Composition) Beeswax between0.01% and 30% Bees Milk between 0.01% and 30% Fruit Wax between 0.1% and5%

Antiseptic solutions such as ethyl alcohol and hydrogen peroxidetypically evaporate at a rapid rate. For this reason, when antisepticsolutions are used alone, they usually have little to no residualeffect. The base oils of the composition, namely citrus sinensis, cocosnucifera, and simmondsia chinensis, are effective to trap the antisepticsolution in a pseudo-emulsion antiseptic that remains active for anextended period of time. This allows the composition to have a longlasting antimicrobial and antiviral protection. The base oils alsoprovide antimicrobial, antiviral and antifungal properties.

When the base oils are combined with the antiseptic solution, asynergistic effect is observed. For instance, the efficacy of any one ofthe base oils or the antiseptic solution, alone, does not exceed 99.99%(4 log). However, when all ingredients are combined in suitable ratiosan unexpected removal efficiency rating (efficacy) of 99.99999% (7 log)or greater is achieved. This synergism is a key to the novelty of thecomposition, providing antimicrobial and antiviral kill levels that aresignificantly greater than those observed in connection with any of theingredients individually or other known antimicrobials and antivirals.

The following examples demonstrate various combinations of ingredients,including the 3 essential ingredients, which have been observed to yieldantimicrobial and antiviral kill rates of 7 log or greater.

EXAMPLE 1

Amount Ingredient (% by Weight of the Composition) USP Ethyl Alcohol(190 proof) 24.9%   Cocos Nucifera 3% Citrus Sinensis 2% Glycine Soja70%  Sodium Benzoate (preservative) 0.1%  

EXAMPLE 2

Amount Ingredient (% by Weight of the Composition) USP Ethyl Alcohol(190 proof) 34.8%   Cocos Nucifera 3% Citrus Sinensis 2% Aloe Vera 3%Lauric Acid 0.1%   Glycine Soja 57%  Sodium Benzoate (preservative)0.1%  

EXAMPLE 3

Amount Ingredient (% by Weight of the Composition) USP Ethyl Alcohol(190 proof) 54.8%  Cocos Nucifera  10% Citrus Sinensis   5% Aloe Vera 30% Lauric Acid 0.1% Glycine Soja 0.1%

EXAMPLE 4

Amount Ingredient (% by Weight of the Composition) USP Ethyl Alcohol(190 proof)  24.9% Cocos Nucifera    8% Citrus Sinensis    8% Aloe Vera29.45% Lauric Acid  0.2% Glycine Soja 29.45%

EXAMPLE 5

Amount Ingredient (% by Weight of the Composition) USP Ethyl Alcohol(190 proof) 24.9%   Emu Oil 3% Citrus Sinensis 2% Glycine Soja 70% Sodium Benzoate (preservative) 0.1%  

EXAMPLE 6

Amount Ingredient (% by Weight of the Composition) Glycine Soja 35%Citrus Sinensis 30% Cocos Nucifera 30% Bees Milk 4.9%  Preservative0.1%  * FOR ALLERGENS AND POLLUTANTS

EXAMPLE 7

Amount Ingredient (% by Weight of the Composition) Bees Milk 50%Lecithin 10% Citrus Sinensis 20% Glycine Soja 19.9%   Preservative0.1%  * FOR ALLERGENS AND POLLUTANTS

EXAMPLE 8

Amount Ingredient (% by Weight of the Composition) USP Ethyl Alcohol(190 proof)  50% Cocos Nucifera   3% Citrus Sinensis   2% Simmondsiachinensis  35% Glycine Soja 9.5% Sodium Benzoate (preservative) 0.1% BHT(preservative) 0.1% Benzalkonium chloride 0.1% Vitamin E 0.2%

EXAMPLE 9

Amount Ingredient (% by Weight of the Composition) USP Ethyl Alcohol(190 proof)  50% Cocos Nucifera   3% Citrus Sinensis   2% Simmondsiachinensis  40% Glycine Soja 4.6% BHT (preservative) 0.1% Benzalkoniumchloride 0.1% Vitamin E 0.2%

EXAMPLE 10

Amount Ingredient (% by Weight of the Composition) USP Ethyl Alcohol(190 proof)  50% Cocos Nucifera   2% Citrus Sinensis  15% Simmondsiachinensis  30% Glycine Soja 2.5% BHT (preservative) 0.1% Benzalkoniumchloride 0.1% Vitamin E 0.3%

In use, the antimicrobial and antiviral composition is applied to theskin surface surrounding the opening of the nostrils according to thefollowing instructions:

-   1). Shake the bottle (containing the composition) well to insure    complete mixture of the ingredients.-   2) Apply approximately 4 drops of the composition to the cotton tip    of a cotton swab so that the cotton tip is fully saturated with the    composition.-   3). Place the thumb and index finger on the swab stem directly below    the wetted cotton tip of the swab. Prepare to apply the composition    to the rim of each nostril just past the nasal opening. Caution: Do    not extend the swab into the nasal canal any further than the short    length of the cotton tip of the swab (about 1 cm or 3.8″). The swab    stem should never enter the nose.-   4). Carefully place only the cotton tip of the swab just inside of    the nostril opening. Using a gentle motion, make 3 or 4 circles to    fully apply the composition to the rim of the nostril. Repeat this    step for the other nostril.-   5). Discard the swab. Gently squeeze the nostrils together to ensure    even distribution of the solution about the rim surrounding each    nostril opening.

In order to evaluate the antimicrobial efficacy of one sample of thecomposition when applied to the proximal external nares of humanvolunteers, the test study was conducted at Bioscience Laboratory, Inc.in Bozeman, Mont. The results of the study are set forth below.

Purpose of Study:

This study was designed to evaluate the persistent antimicrobialefficacy of one (1) test product intended for prevention of airborneillness when applied within the proximal nares (the first 0.25″ of anaris) and one (1) control material.

Scope of Study:

Thirty (30) human subjects were evaluated in this study. Twenty-five(25) human subjects were used to evaluate the test product, and five (5)human subjects were used to evaluate the control material (steriledeionized water). Samples were taken from the proximal nares (the first0.25″ of the nostrilar canal). Baseline samples were collected a minimumof twenty-four (24) hours apart to allow recolonization of the normalflora. On the test day, the product was applied to each naris. Eachnaris was apportioned on a sagittal plane into two (2) sample sites,medial and lateral. Ten (10) samples each were taken for the two (2)hour±fifteen (15) minutes and four (4) hour±fifteen (15) minutespost-product exposures to the test product, and for the immediate(within one [1] minute of application) and four (4) hour±fifteen (15)minutes post-product exposures to the control material. Twenty (20)samples each were taken for the immediate (within one [1] minute ofapplication), six (6) hour±fifteen (15) minutes, eight (8) hour±fifteen(15) minutes, and twelve (12) hour±fifteen (15) minutes post-productexposures to the test product.

Validation of the Neutralizer System:

A neutralization study was performed to assure the effectiveness of theneutralizers used in the diluting medium. The neutralization followedguidelines set forth in ASTM E 1054-02, Standard Test Methods forEvaluation of Inactivators of Antimicrobial Agents, except that themicroorganism was added to the neutralizers prior to the addition of thetest or comparison antiseptic. Staphylococcus aureus (ATCC #6538) wasused as the challenge species in the neutralizer validation study. Theneutralization study demonstrated that the antimicrobial activities ofthe test and reference products were effectively eliminated.

Adverse Events:

No Adverse Events were observed during or following completion of thisstudy.

Results:

Table I presents the statistical summary of the log 10 recovery valueswith relation to use of the Test Product.

TABLE I Statistical Summary of the log 10 Recovery Values for the TestProduct 95% Standard Confidence Log₁₀ Sample Sample Size Mean DeviationInterval Reduction Baseline 25 4.51 0.39 4.35 to 4.67 N/A PooledImmediate 21 3.38 1.28 2.79 to 3.96 1.13 Post-Product Exposure 2 Hours11 3.61 1.14 2.85 to 4.38 0.90 Post-product Exposure 4 Hours 9 3.58 0.563.15 to 4.02 0.93 Post-Product Exposure 6 Hours 18 3.59 0.52 3.34 to3.85 0.92 Post-Product Exposure 8 Hours 21 3.88 0.65 3.58 to 4.71 0.63Post-Product Exposure 12 Hours 19 4.28 0.67 3.96 to 4.60 0.23Post-Product ExposureTable II presents the Statistical Summary of the log 10 recovery valueswith relation to use of the Control Material (Sterile Deionized Water)

TABLE II Statistical Summary of the log 10 Recovery Values for theControl Material Sterile Deionized Water 95% Standard Confidence Log₁₀Sample Sample Size Mean Deviation Interval Reduction Baseline 5 4.310.49 3.70 to 4.92 N/A Pooled Immediate 10 4.66 0.59 4.24 to 5.08 0.00Post-Product Exposure 4 Hours 10 4.23 0.63 3.78 to 4.68 0.08Post-Product Exposure

While the composition of the present invention has been described andexemplified according to several preferred embodiments thereof, it isrecognized that departures from the instant disclosure are fullycontemplated within the spirit and scope of the invention which is notto be limited except as defined in the following claims as interpretedunder the Doctrine of Equivalents.

1. An antimicrobial, antiviral and antifungal composition comprising:ethyl alcohol in an amount of between 5.0% and 75.0% by weight of thecomposition; orange oil in an amount of between 0.05% and 60.0% byweight of the composition; jojoba oil in an amount of between 0.1% and75.0% by weight of the composition; grapefruit seed extract in an amountof between 0.1% and 8.0% by weight of the composition; and aloe vera inan amount of between 0.1% and 30.0% by weight of the composition.